A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of BTX 1503 in Patients with Moderate to Severe Acne Vulgaris
- Conditions
- Acne vulgarisSkin - Dermatological conditions
- Registration Number
- ACTRN12618001047280
- Lead Sponsor
- Botanix Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 386
To be included in the study, subjects with acne vulgaris must meet the following inclusion criteria.
- Subject is of either gender and 12 to 40 years of age.
- Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
- Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
-Subject has acne vulgaris of the face defined as:
a. 20 to 50 (inclusive) inflammatory lesions on the face
b. 20 to 100 (inclusive) non-inflammatory lesions on the face
c. An Investigator Global Assessment (IGA) score for acne severity of 3 or 4 (moderate or severe) assessed on the face.
-Subject has less than or <3 nodular/cystic acne lesions (>5 mm in diameter).
-Subject must refrain from the use of other treatments for acne during the study.
-Subject must agree to not wash or shave their face, swim or otherwise get their face wet for at least 1 hour after application of study medication.
-Subject must agree to maintain their regular use of sunscreens, moisturizers, shaving cream, and facial make up throughout the entire course of the study.
- Sexually active women of childbearing potential must use appropriate birth control methods.
-People who would otherwise qualify for the study but are living in the same household as a study subject, are not allowed to participate in the study.
-Female subject who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study.
-Subject has acne conglobata, acne fulminans, secondary acne (chloracne), pseudo-folliculitis, severe acne requiring systemic treatment, or is taking a medication known to induce or exacerbate acne.
-Subject has severe truncal acne.
-Subject has excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris.
-Subject has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to evaluate the skin of the face.
-Subject has any skin condition of the face other than acne vulgaris.
-Subject has used oral retinoid (e.g. isotretinoin) within 6 months (180 days) prior to the
-Subject has used Vitamin A supplements greater than 10,000 units/day within 6 months (180 days) prior to the Baseline Visit.
-Subject has used androgen receptor blockers (such as spironolactone or flutamide) within 3 months (90 days) prior to the Baseline Visit.
-Subject has initiated treatment with hormonal therapy or changed dosing with hormonal therapy within 3 months (90 days) prior to the Baseline Visit. Note: Dose and frequency of any hormonal therapy started more than 3 months (90 days) prior to the Baseline Visit must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, anabolic steroids and birth control pills. Subjects taking testosterone therapy are excluded from participation.
-Subject has had facial procedures (chemical or laser peel, microdermabrasion, etc.) within 8 weeks (56 days) prior to the Baseline Visit.
-Subject has had treatment with systemic antibiotics within 4 weeks (28 days) prior to the Baseline Visit.
-Subject has had treatment with systemic anti-acne drugs within 4 weeks (28 days) prior to the Baseline Visit.
-Subject has had treatment with systemic anti-inflammatory drugs within 4 weeks (28 days) prior to the Baseline Visit.
Note: Occasional non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis, and if not used consecutively for >14 days prior to the Baseline Visit, is acceptable and does not require washout. Subjects receiving intranasal and inhaled corticosteroids may participate. Low dose (81mg) aspirin taken daily is acceptable.
-Subject has had treatment with systemic (oral) corticosteroids other immunosuppressive medications within 4 weeks (28 days) prior to the Baseline Visit.
-Subject has had treatment with prescription topical retinoid use on the face (e.g. tretinoin, tazarotene) within 4 weeks (28 days) prior to the Baseline Visit.
-Subject has had treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide) or combination products that include a topical antibiotic within 2 weeks (14 days) prior to the Baseline Visit.
-Subject has had treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, adapalene, a-hydroxy/glycolic acid on the face within 2 weeks (14 days) prior to the Baseline Visit.
-Subject has had photodynamic therapy within 8 week
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute change from Baseline in inflammatory lesion counts <br>The counts will be performed by a dermatologist or other trained study investigator.[Day 84 post-baseline visit]
- Secondary Outcome Measures
Name Time Method